Statement from PATH: HPV demonstration project in India

Contact: Amy MacIver, 206.302.4522, amaciver@path.org.

Seattle, May 11, 2011—In 2010, the Government of India formed an Inquiry Committee to review studies being conducted in India on the use of licensed and approved vaccines against human papillomavirus (HPV), the main cause of cervical cancer. PATH has fully cooperated in the inquiry process and would like to thank the inquiry committee for the time and dedication they have devoted to this matter. PATH welcomes opportunities to contribute to discussions that increase public confidence in comprehensive prevention measures against life-threatening diseases, such as cervical cancer. Above all, PATH is committed to meeting the highest scientific, ethical, and legal standards and we appreciate that the inquiry committee determined that there has been no major violation of any ethical norm in the conduct of the study.

Cervical cancer kills an estimated 72,000 Indian women every year. The great tragedy is that these deaths are largely preventable. The goal of PATH’s comprehensive cervical cancer prevention work in India is to save the lives of women through both vaccinations and accessible pre-cancer screening and treatment. The post-licensure observational study (or “demonstration project”) was designed to generate data about the feasibility and implementation costs associated with different HPV vaccine delivery strategies. The study did not seek to evaluate the efficacy or long-term safety of these licensed, approved HPV vaccines. The efficacy and safety of these vaccines have already been established through rigorous clinical trials in India and other countries. Short-term safety was tracked through the routine vaccine safety monitoring system used for all licensed vaccines in India. The coverage, feasibility, acceptability, and implementation data gained from this study will provide the government with information needed for decision-making about whether—and how—to integrate the vaccine into India’s public-sector immunization program.

The study was implemented through a collaboration between PATH, the Indian Council of Medical Research (ICMR) and the state governments of Andhra Pradesh (AP) and Gujarat (GJ). It was implemented with approval by ethical review committees (the Institutional Ethics Committee for Human Research [IECHR] of Baroda Medical College, MNJ Institute of Oncology and Regional Cancer Center, and the Western Institutional Review Board [WIRB]), by the Drugs Controller General of India and the Health Ministry’s Screening Committee (HMSC) and by multidisciplinary and multi-stakeholder project advisory groups as well.

The HPV vaccines used in this project have been licensed and approved by the Drug Controller General of India (DCGI) and recommended by the Federation of Obstetric and Gynaecological Societies of India (FOGSI), the Indian Academy of Pediatrics (IAP), and the World Health Organization (WHO). These vaccines are already widely used in India by private medical providers, but are not available from the Indian public health system.

Globally, HPV vaccines are included in the national immunization programs of more than 33 countries worldwide. To date, not a single death has been shown to be caused by HPV vaccines anywhere in the world. The Inquiry Committee findings are consistent with those international data in that the Committee did not identify any evidence suggesting that any deaths, or any long-term, serious health problems, were caused by HPV vaccination in India.

PATH is an international nonprofit organization whose mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. PATH is committed to meeting the highest scientific, ethical, and legal standards in its work to improve health for the people of India and other countries around the world. In particular, PATH is committed to continuing its efforts to address the burden of cervical cancer in India, a disease that severely impacts the quality of life of women and families throughout the country.